18 June 2021 | Friday | News
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Data Presented at the Global Hepatitis Summit Show that Virally Suppressed Patients from Taiwan with Renal or Hepatic Impairment had High Rates of Viral Suppression and Improved or Stable Bone and Renal Parameters, Following Switching to Vemlidy® --
Gilead Sciences, Inc. today announced new sub-analysis data from a Phase 2 open-label study (GS-US-320-4035; NCT03180619), evaluating the safety and efficacy of switching to Vemlidy®# (tenofovir alafenamide 25 mg, TAF) from tenofovir disoproxil fumarate (TDF) and/or other oral antiviral treatment (OAV) among virally suppressed hepatitis B patients with renal or hepatic impairment. The data presented at the Global Hepatitis Summit (GHS) 2021 (18-20 June) demonstrate Vemlidy provides high rates of viral suppression and stable or improved markers of renal and bone safety in a subset analysis of patients from Taiwan who were enrolled in GS-US-320-4035.
A total of 124 patients recruited for the study were given TAF 25mg once daily for 96 weeks. Patients who were previously either on TDF or other OAVs were enrolled in one of two groups: Part A (renal impairment) or Part B (hepatic impairment). Among the 124 patients, 33 patients were from Taiwan (22 patients in Part A and 11 patients in Part B). Sub-analyses of the data from the Taiwan patients showed that the majority maintained viral suppression and had stable or slightly improved bone and renal parameters after 96 weeks of TAF treatment. No patients from Taiwan discontinued treatment due to an adverse event. Results of this study will be presented at GHS [Poster #310 (part A) & Poster #315 (part B)].
"These latest sub-analyses reinforce the role of Vemlidy in the treatment of chronic hepatitis B infection. With the additional data, healthcare providers can be confident that Vemlidy is an effective and durable option even for patients with other conditions such as hepatic or renal impairment," said Betty Chiang, Vice President of Medical Affairs, International, Gilead Sciences.
In addition to the Phase 2 switch study, Gilead will also be presenting a poster at GHS, titled Gilead Sciences' Commitment to Global Elimination of Hepatitis C [Poster #135], on its strategy and initiatives, including educational programs, investigator-sponsored research projects, program grants, and technology transfer and voluntary licensing for hepatitis C elimination.
Gilead supports the efforts of governments and partners with professional and community-based organizations, healthcare providers, and payers to accelerate progress toward the WHO's 2030 hepatitis B and C elimination goals.